"Regulatory expectations are driving leading companies to incorporate transport testing into both their development and stability programs,” said Modality Solutions President Gary Hutchinson.
HOUSTON, Tex. (PRWEB) July 17, 2018
The cold chain experts at Modality Solutions have published and made available for free its new white paper - Drug Product Formulation Testing with Transport Simulation. The full-service engineering firm provides simulated testing for drug product formulations. The goal of the drug formulation simulation study is to concurrently expose drug product to all five environmental hazards – temperature, shock, vibration, humidity, and pressure - as they occur during real-world distribution.
With Modality Solutions, three types of firms – cold chain regulatory filing authority, logistics network operations, and an integrated expertise staffing firm – combine as a single source for cold chain management integration for the life sciences industry.
The Drug Product Formulation Testing with Transport Simulation white paper outlines a new approach for stability studies. The new study uses an integrated methodology for testing for the different hazards as they occur in the supply chain.
During the simulation testing, industry standards in the following areas were questioned, tested, and analyzed:
- Hot and cold temperature profiles
- Non-accelerated vibration effects
- Exposure to multiple pressure gradients
- Parcel-based drop/shock events
An understanding of the shipping lanes is necessary to ensure the simulated transport reflects the actual cold chain. If correctly planned and executed, analytical results from samples exposed to concurrent transport simulation included in the BLA (Biologic License Application) filing are considered industry best practice.
An initial transport simulation study is advised well before filing. This first test may be on engineering batches or prior to a final formulation decision. This allows for an appraisal of multiple candidate formulations, de-risks the subsequent development path, and builds product knowledge at the earliest possible time in development.
Inclusion of data from samples exposed to the appropriate simulated hazards (shock, vibration, temperature, humidity, and pressure) can replace the need for extensive studies from actual shipments. A sufficient number of samples from the validation batches are used for this test and analyzed with the registration stability samples. This allows a comparison to be made between transported and quiescent samples. The results are then shared in the BLA filing.
“Regulatory expectations are driving leading companies to incorporate simulated transport testing into both their development and stability programs,” said Modality Solutions President Gary Hutchinson. “Our Advantage Transport Simulation Laboratory™ enables the study of transport stresses on early-stage drug formulations during the development process and verification of the robustness of the commercial drug product formulation.”
Click here to download the Drug Product Formulation Testing with Transport Simulation White Paper.
For more information about Modality Solutions, visit modality-solutions.com
About Modality Solutions, LLC
Founded in 2011 Modality Solutions integrates cold chain operations systems ensuring regulatory compliance, product quality, and patient safety by combining best practices of process validation, systems qualification, and risk assessment. Modality delivers proper documentation for qualification, validation and training aligned with the necessary procedural controls, visual controls, and monitoring. Key areas of service are: ensuring regulatory compliance; delivering cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conducting transport simulation testing; providing staffing augmentation; decreasing development cycle times for a faster route-to-market; developing transport validation strategies to support global regulatory applications; and clinical trial operations. For more information, visit modality-solutions.com